Phase 1 Study for IPG11406 in Health Volunteer

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Food Effect of Orally Administered IPG11406 in Healthy Adult Participants

A phase 1, randomized, double-blind, placebo-controlled, single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and food effect of orally administered IPG11406 in healthy adult participants

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Drug: IPG11406

Detailed Description

This is a phase 1, randomized, double-blind, placebo-controlled, single and multiple dose escalation study to evaluate the safety, tolerability, PK and food effect of orally administered IPG11406 in healthy adult participants. The study will involve two sequential parts: a single ascending dose (SAD) period (Part A) followed by a multiple ascending dose (MAD) period (Part B).

Part A Dose escalation will start from 0.5 mg. Currently, the 6 dose cohorts are Cohort 1 (0.5 mg), Cohort 2 (2 mg), Cohort 3 (6 mg), Cohort 4 (20 mg), Cohort 5 (40 mg), Cohort 6 (80 mg). About 42 healthy adult participants are being sequentially enrolled in 6 cohorts.

There are 6 participants in Cohort 1 to Cohort 3. In each cohort, 4 participants will receive IPG11406 and 2 participants will receive the placebo as per the randomization code.

Approximately 8 participants will be enrolled in Cohort 4 to Cohort 6 respectively; in each cohort, 6 participants will receive IPG11406 and 2 participants will receive the placebo as per the randomization code.

In each Cohort, 2 sentinel participants will be dosed at least 48 hours prior to the remaining participants. One sentinel will be dosed with IPG11406 and the other with a matching placebo. The remaining participants will be dosed only if no significant safety issues are identified in the sentinel participants. Doses and sampling intervals may be modified based on the PK and safety data that emerges throughout the study.

One of the SAD (Cohort 5 is tentatively to be selected, it may be modified based on the decision of SMC meeting.) cohorts will be selected to assess the effect of food on the pharmacokinetic parameters and referred to as the food effect (FE) cohort. Participants in this cohort will be requested to return to the clinical site to receive a second dose of IPG11406 or placebo after the administration of a meal, upon completion of the 4-day safety follow up period after their first dose. The second dose of IPG11406 or placebo will be administered following a standardized high fat meal (total calories approximately 800 to 1000 calories, with approximately 50% of total calories from fat).

Healthy participants will be screened within 28 days prior to dosing. Participants in the SAD cohorts (including FE cohort) will be admitted to the study site on Day -1 for a total of 6 days. Administration of a single dose of IPG11406 or the placebo will occur on Day 1 under fasted conditions (Following an overnight fast of at least 10 hours, subjects will receive a single dose of IPG11406 or placebo with 240 mL water. Water can be ingested as desired except for 1 hour pre-dose until one hour post dose.). Participants will be discharged on Day 5 following collection of samples for PK analyses and the completion of safety assessments. A follow-up visit will occur on Day 8.

Participants in the FE cohort will be admitted to the study site for at least 10 days for the 2 administrations of IPG11406. A washout of ≥ 4 days will be included between investigational product (IP) administrations. Administration of a single dose of IPG11406 or placebo will occur on Day 1 under fasted condition, and Day 6 (anticipated) under postprandial condition. Following completion of all safety assessments and sampling for PK analyses, subjects will be discharged on Day 10 (anticipated) after the second dose. There will be a follow-up visit on Day 13 (anticipated) after the single dose administration in each period.

Once the final participant in the cohort has completed the Day 5 assessments and been discharged, the Safety Monitoring Committee (SMC) will review cumulative blinded safety data (including follow-up visit data from preceding cohorts) and available PK data to determine the safety and tolerability of the study drug. If the dose level is determined to be safe and well-tolerated, the next dose cohort will be enrolled and randomized in preparation to receive the next dose level of IPG11406 or the placebo.

Part B Three dose levels (10 mg, 20 mg and 40 mg) are anticipated to be evaluated in the MAD, once daily. There will be approximately 8 subjects per cohort, 6 subjects will receive IPG11406 and 2 subjects will receive placebo per the randomization code.

For Cohort M1 (10 mg), the MAD phase will commence following the establishment of the safety and tolerability of Cohort 4 (20 mg) in the SAD. The SMC will evaluate the safety, tolerability and PK data obtained from the participants of cohort 4 in the SAD to determine if the Cohort M1 will be enrolled and randomized to receive the 10 mg multiple dose levels of IPG11406 or placebo.

For Cohort M2 (20 mg), the SMC will evaluate the safety, tolerability and PK data obtained from the participants of cohort 5 (40 mg) in the SAD as well as the safety and PK data from Cohort M1 to determine if the Cohort M2 will be enrolled and randomized to receive the 20 mg multiple dose levels of IPG11406 or placebo.

For Cohort M3 (40 mg), the SMC will evaluate the safety, tolerability and PK data obtained from the participants of cohort 6 (80 mg) in the SAD as well as the safety and PK data from Cohort M2 to determine if the Cohort M3 will be enrolled and randomized to receive the 40 mg multiple dose levels of IPG11406 or placebo.

All subjects will be screened within 28 days prior to dosing and will be admitted to the study site on Day -1. Dosing will start on the morning of Day 1 and will continue over a 10-day period at each dose level. Blood draws will be collected for the assessment of PK parameters. Participants will be discharged on Day 14 following completion of all PK sample collection and safety assessments. There will be a follow-up visit 7 days after the last dose.

Once the final participant in the cohort has completed the Day 14 assessments and been discharged, the SMC will review blinded cumulative safety data (including the follow-up visit data) and available PK data to determine the safety and tolerability of the study drug.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310013
      • Zhejiang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Participants must meet all of the following criteria to be included in the study:

Demography

1. Healthy volunteers aged between 18 and 50 years old, both male and female, are required. Participants must undergo medical history investigation, physical examination, vital signs examination, electrocardiogram, chest X-ray examina-tion, and laboratory tests during the screening period to ensure good health.
2. The body mass index (BMI) is between 18 and 32, calculated as: BMI= weight(kg)/ height 2(m 2);
3. Participants were required to be in a non-menstrual, non-pregnant, and non-lactating period during the trial and to agree to have no childcare plans for the next 6 months.
4. Physical health, defined as: detailed and clear medical history, comprehensive physical examination (including blood pressure and pulse rate, laboratory tests, and 12-lead electrocardiogram) with no clinical abnormalities detected;
5. After 10 minutes of supine position testing, vital signs should be within the following range: 95 mmHg <systolic blood pressure (SBP) <140 mmHg 45 mmHg <Diastolic Blood Pressure (DBP) <90 mmHg 45 bpm <Heart Rate (HR) <90 bpm
6. After 10 minutes of resting supine position, 12-lead ECG readings: PR interval<120 ms <220 ms, QRS complex <120 ms, QTc (Fridericia recommendedalgorithm) ≤450 ms, normal ECG; or abnormal ECG results deemed clinically insignificant by the investigator.
7. Laboratory test results must fall within the normal range (or within the established screening threshold) or show no clinically significant abnormalities; however, serum creatinine, alkaline phosphatase, and liver enzymes (aspartate aminotransferase,Alanine aminotransferase (ALT) should not exceed the upper limit of the laboratory normal range. Total bilirubin should not exceed 1.5 times the upper limit of the normal range for conjugated bilirubin (unless the subject has a history of Gilbert syndrome).
8. Willing and able to comply with all treatment, and laboratory testing protocols, agree to take the oral test medication, and meet other study requirements

9. Contraceptive requirements for female subjects:

   1. Fertile female participants: Must undergo a urine pregnancy test during the screening period with a negative result, and agree to use effective contraception for 3 months after signing the informed consent until the last dose of the investigational drug. Contraception must always be strictly followed according to the instructions of the contraceptive product and the investigator. Effective contraception includes: complete abstinence, intra- uterine device (IUD) or intrauterine contraceptive system (IUS), double- barrier method (e.g., spermicide plus male condom, female condom, diaphragm, cervical cap, or intrauterine device), or a partner who has undergone vasectomy and whose semen cannot be detected for sperm. b. Fertile women: This includes postmenopausal women (with complete cessation of menstruation for ≥1 year) or women with surgical records of hysterectomy, bilateral oophorectomy, or bilateral salpingectomy (as opposed to tubal ligation). Fertile women do not need to adhere to the listed contraceptive measures. 10. Contraceptive requirements for male subjects: Male subjects must agree to use the listed effective contraceptive methods or have undergone vasectomy within 3 months after signing the informed consent and receiving the last dose ofthe investigational drug. 11. Participants must provide informed consent for this study prior to enrollment and voluntarily sign a written informed consent form.

Exclusion Criteria:

Participants who meet any of the following criteria will be excluded from the study:

Medical history and clinical status

1. History of severe cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immune, dermatological, neurological, or psychiat ric disorders. 2. Abnormal chest X-ray findings. 3. Recurrent headache and/or migraine, recurrent nausea and/or vomiting (vomiting only: more than twice a month). 4. Blood donation within 2 months prior to inclusion is permitted, with no volume restrictions. 5. Symptomatic or asymptomatic orthostatic hypotension: defined as a drop in systolic blood pressure of ≥30 mmHg within 3 minutes when changing from supine to standing position. 6. History of drug allergy or confirmed allergic disease. 7. Known to be allergic to any component ofthe pharmaceutical preparation. 8. History of drug or alcohol abuse (regular daily alcohol intake exceeding 40 mL). 9. Heavy smokers (smoking 5 or more cigarettes per day). For light smokers (smoking fewer than 5 cigarettes per day), smoking should be discontinued during the trial period. 10. Individuals who consume excessive amounts oftea or coffee (more than 8 cups per day). 11. Take any medication within 14 days before inclusion or within 5 times the half-life or pharmacodynamic half-life ofthe medication; 12. Eat any citrus fruit (e.g. grapefruit, orange) or juice in the 5 days before selection. 13. Any vaccination within 28 days prior to inclusion and any injection of a biological agent (antibody or its derivative) within 4 months. 14. According to the investigators' assessment, the subjects may have poor compliance during the study or may not be able to cooperate due to language issues or intellectual developmental delays. 15. Participants were registered or had previously participated in any other clinical study involving a drug clinical trial or any other type of medical research within 3 months prior to enrollment or within the 5 half-life period (whichever is shorter). 16. Participants who could not be contacted in an emergency. 17. Researchers or associate researchers, research assistants, pharmacists, study coordinators, or other staff members who are directly or indirectly involved in the study, or anyone associated with the study site (including employees or immediate family members). 18. Any of the following tests are positive: hepatitis B surface antigen (HBsAg), hepatitis B core antigen (anti-HBcAg), anti-HCV antibody, anti-human immunodeficiency virus 1 and 2 antibody (anti-HIV1 and anti-HIV2 Ab), or Treponema pallidum antibody. 19. Positive urine drug screening (amphetamines/methamphetamine, barbiturates, benzodiazepines, cannabinoids, cocaine, opioids). 20. Alcohol test positive. 21. Subjects with difficulty in venous blood collection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 (SAD - 0.5 mg); 4 subjects in this cohort will receive a single dose of IPG11406 0.5 mg qd and 2 subjects will receive a single dose of placebo 0.5 mg qd orally.	Drug: IPG11406; IPG11406 Activity: An antagonist of the GPR183 Dosage form: Tablet Strength: 0.5 mg, 10 mg and 40 mg Storage：15 ~ 25 °C in a tightly sealed container, protect from light Administration: In each cohort, IPG11406 or placebo tablets are orally administered once on Day 1 (Part A) or daily for 10 days from Day 1 to Day 10 (Part B) in a fasted state. Oral doses will be administered with 240 ml of water. Tablets should not be chewed or crushed. Participants in the FE Cohort will receive a second single dose of IPG11406 following a standardized high fat meal upon ≥4 days washout period after the first dose. IPG11406 Placebo Placebo tablets: tablets identical to IPG11406 tablets; Other Names: IPG11406 Placebo
Experimental: Cohort 2 (SAD - 2 mg); 4 subjects in this cohort will receive a single dose of IPG11406 2 mg qd and 2 subjects will receive a single dose of placebo 2 mg qd orally.	Drug: IPG11406; IPG11406 Activity: An antagonist of the GPR183 Dosage form: Tablet Strength: 0.5 mg, 10 mg and 40 mg Storage：15 ~ 25 °C in a tightly sealed container, protect from light Administration: In each cohort, IPG11406 or placebo tablets are orally administered once on Day 1 (Part A) or daily for 10 days from Day 1 to Day 10 (Part B) in a fasted state. Oral doses will be administered with 240 ml of water. Tablets should not be chewed or crushed. Participants in the FE Cohort will receive a second single dose of IPG11406 following a standardized high fat meal upon ≥4 days washout period after the first dose. IPG11406 Placebo Placebo tablets: tablets identical to IPG11406 tablets; Other Names: IPG11406 Placebo
Experimental: Cohort 3 (SAD - 6 mg); 4 subjects in this cohort will receive a single dose of IPG11406 6 mg qd and 2 subjects will receive a single dose of placebo 6 mg qd orally.	Drug: IPG11406; IPG11406 Activity: An antagonist of the GPR183 Dosage form: Tablet Strength: 0.5 mg, 10 mg and 40 mg Storage：15 ~ 25 °C in a tightly sealed container, protect from light Administration: In each cohort, IPG11406 or placebo tablets are orally administered once on Day 1 (Part A) or daily for 10 days from Day 1 to Day 10 (Part B) in a fasted state. Oral doses will be administered with 240 ml of water. Tablets should not be chewed or crushed. Participants in the FE Cohort will receive a second single dose of IPG11406 following a standardized high fat meal upon ≥4 days washout period after the first dose. IPG11406 Placebo Placebo tablets: tablets identical to IPG11406 tablets; Other Names: IPG11406 Placebo
Experimental: Cohort 4 (SAD - 20 mg); 6 subjects in this cohort will receive a single dose of IPG11406 20 mg qd and 2 subjects will receive a single dose of placebo 20 mg qd orally.	Drug: IPG11406; IPG11406 Activity: An antagonist of the GPR183 Dosage form: Tablet Strength: 0.5 mg, 10 mg and 40 mg Storage：15 ~ 25 °C in a tightly sealed container, protect from light Administration: In each cohort, IPG11406 or placebo tablets are orally administered once on Day 1 (Part A) or daily for 10 days from Day 1 to Day 10 (Part B) in a fasted state. Oral doses will be administered with 240 ml of water. Tablets should not be chewed or crushed. Participants in the FE Cohort will receive a second single dose of IPG11406 following a standardized high fat meal upon ≥4 days washout period after the first dose. IPG11406 Placebo Placebo tablets: tablets identical to IPG11406 tablets; Other Names: IPG11406 Placebo
Experimental: Cohort 5 (SAD - 40 mg); 6 subjects in this cohort will receive a single dose of IPG11406 40 mg qd and 2 subjects will receive a single dose of placebo 40 mg qd orally.	Drug: IPG11406; IPG11406 Activity: An antagonist of the GPR183 Dosage form: Tablet Strength: 0.5 mg, 10 mg and 40 mg Storage：15 ~ 25 °C in a tightly sealed container, protect from light Administration: In each cohort, IPG11406 or placebo tablets are orally administered once on Day 1 (Part A) or daily for 10 days from Day 1 to Day 10 (Part B) in a fasted state. Oral doses will be administered with 240 ml of water. Tablets should not be chewed or crushed. Participants in the FE Cohort will receive a second single dose of IPG11406 following a standardized high fat meal upon ≥4 days washout period after the first dose. IPG11406 Placebo Placebo tablets: tablets identical to IPG11406 tablets; Other Names: IPG11406 Placebo
Experimental: Cohort 6 (SAD - 80 mg); 6 subjects in this cohort will receive a single dose of IPG11406 80 mg qd and 2 subjects will receive a single dose of placebo 80 mg qd orally.	Drug: IPG11406; IPG11406 Activity: An antagonist of the GPR183 Dosage form: Tablet Strength: 0.5 mg, 10 mg and 40 mg Storage：15 ~ 25 °C in a tightly sealed container, protect from light Administration: In each cohort, IPG11406 or placebo tablets are orally administered once on Day 1 (Part A) or daily for 10 days from Day 1 to Day 10 (Part B) in a fasted state. Oral doses will be administered with 240 ml of water. Tablets should not be chewed or crushed. Participants in the FE Cohort will receive a second single dose of IPG11406 following a standardized high fat meal upon ≥4 days washout period after the first dose. IPG11406 Placebo Placebo tablets: tablets identical to IPG11406 tablets; Other Names: IPG11406 Placebo
Experimental: Cohort 7 (MAD - 10 mg); 6 subjects in this cohort will receive a dose of IPG11406 10 mg qd and 2 subjects will receive a dose of placebo 10 mg qd orally from Day 1 to 10-day.	Drug: IPG11406; IPG11406 Activity: An antagonist of the GPR183 Dosage form: Tablet Strength: 0.5 mg, 10 mg and 40 mg Storage：15 ~ 25 °C in a tightly sealed container, protect from light Administration: In each cohort, IPG11406 or placebo tablets are orally administered once on Day 1 (Part A) or daily for 10 days from Day 1 to Day 10 (Part B) in a fasted state. Oral doses will be administered with 240 ml of water. Tablets should not be chewed or crushed. Participants in the FE Cohort will receive a second single dose of IPG11406 following a standardized high fat meal upon ≥4 days washout period after the first dose. IPG11406 Placebo Placebo tablets: tablets identical to IPG11406 tablets; Other Names: IPG11406 Placebo
Experimental: Cohort 9 (MAD - 40 mg); 6 subjects in this cohort will receive a dose of IPG11406 40 mg qd and 2 subjects will receive a dose of placebo 40 mg qd orally from Day 1 to 10-day.	Drug: IPG11406; IPG11406 Activity: An antagonist of the GPR183 Dosage form: Tablet Strength: 0.5 mg, 10 mg and 40 mg Storage：15 ~ 25 °C in a tightly sealed container, protect from light Administration: In each cohort, IPG11406 or placebo tablets are orally administered once on Day 1 (Part A) or daily for 10 days from Day 1 to Day 10 (Part B) in a fasted state. Oral doses will be administered with 240 ml of water. Tablets should not be chewed or crushed. Participants in the FE Cohort will receive a second single dose of IPG11406 following a standardized high fat meal upon ≥4 days washout period after the first dose. IPG11406 Placebo Placebo tablets: tablets identical to IPG11406 tablets; Other Names: IPG11406 Placebo
Experimental: Cohort 8 (MAD - 20 mg); 6 subjects in this cohort will receive a dose of IPG11406 20 mg BID and 2 subjects will receive a dose of placebo 20 mg BID orally from Day 1 to 10-day.	Drug: IPG11406; IPG11406 Activity: An antagonist of the GPR183 Dosage form: Tablet Strength: 0.5 mg, 10 mg and 40 mg Storage：15 ~ 25 °C in a tightly sealed container, protect from light Administration: In each cohort, IPG11406 or placebo tablets are orally administered once on Day 1 (Part A) or daily for 10 days from Day 1 to Day 10 (Part B) in a fasted state. Oral doses will be administered with 240 ml of water. Tablets should not be chewed or crushed. Participants in the FE Cohort will receive a second single dose of IPG11406 following a standardized high fat meal upon ≥4 days washout period after the first dose. IPG11406 Placebo Placebo tablets: tablets identical to IPG11406 tablets; Other Names: IPG11406 Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety Indicators：Adverse Event	from first dose until end of follow-up, up to 17 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic Indicators: Maximum Plasma Concentration (Cmax)	Peak concentration. It is directly obtained from the actual measured data of blood drug concentration-time. Steady-state maximum plasma concentration. Obtained directly from the measured plasma concentration-time data. Cohort1-Cohort6:Day 1, 6 hours before administration (within 1 hour); after administration, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 36, 48, 72, 96 hours Cohort7-Cohort9:Day 1: Before administration (within 1 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24 hours after administration. Day 4, Day 6, Day 8: Before administration (within 1 hour before administration). Day 10: Before administration (within 1 hour before administration), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 36, 48, 72, 96 hours after administration.	Up to 10 days
Pharmacokinetic Indicators: Area Under the Plasma Concentration Versus Time Curve (AUC)	From the last administration to the area under the blood concentration-time curve of the last measurable concentration. Calculated using the linear trapezoidal method: AUC(i, i+1) = (Ti+1 - Ti)(Ci + Ci+1) / 2, AUC0-t is the sum of all AUC(i, i+1). Cohort1-Cohort6:Day 1, 6 hours before administration (within 1 hour); after administration, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 36, 48, 72, 96 hours Cohort7-Cohort9:Day 1: Before administration (within 1 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24 hours after administration. Day 4, Day 6, Day 8: Before administration (within 1 hour before administration). Day 10: Before administration (within 1 hour before administration), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 36, 48, 72, 96 hours after administration.	Up to 10 days
Pharmacokinetic Indicators:Time to Maximum Concentration (Tmax)	Steady-state time to Cmax. Obtained directly from the measured plasma concentration-time data. Defined as the time of the first occurrence of Cmin, ss (when there are multiple maximum plasma concentrations), unless otherwise specified	Up to 10 days

Collaborators and Investigators

• Sponsor: Nanjing Immunophage Biotech Co., Ltd
• Collaborators: Zhejiang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2024
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: December 25, 2023
• First Submitted That Met QC Criteria: February 3, 2024
• First Posted (Actual): February 13, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases
• Other Study ID Numbers: IPG11406-C001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No