To Evaluate Safety, Tolerability, PK/PD & Food Effect of Single/Multiple Oral TUL321 Capsules in Healthy Participants.

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Characteristics of Single and Multiple Doses of TUL321 Capsule in Healthy Participants, and the Effect of Food on Pharmacokinetics

Phase I Study Evaluating Safety, Tolerability, PK and PD of Single and Multiple Doses of TUL321 Capsule in Healthy Participants and Food Effect on PK

Study Overview

• Status: Recruiting
• Conditions: Paroxysmal Nocturnal Hemoglobinuria, PNH
• Intervention / Treatment: Drug: Part1: TUL321; Drug: Part2: TUL321; Drug: Part1: Placebo; Drug: Part2: Placebo

Detailed Description

Primary Objective:

To evaluate the safety and tolerability following single and multiple oral dministrations of TUL321 capsules in healthy participants.

Secondary Objectives:

1. To characterize the pharmacokinetic (PK) profiles following single and multiple oral administrations of TUL321 capsules in healthy participants;
2. To evaluate the effect of a high-fat meal on the PK profiles after a single oral administration of TUL321 capsules in healthy participants;
3. To preliminarily assess the in vivo biotransformation and mass balance characteristics following single oral administration of TUL321 capsules;
4. To characterize the pharmacodynamic (PD) profiles following single and multiple oral administrations of TUL321 capsules in healthy participants;
5. To evaluate the effect of single oral administration of TUL321 capsules on the QT/QTc interval.

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Guoping Yang; Phone Number: +86-13974817168; Email: ygp9880@163.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Third Xiangya Hospital of Central South University
      • Contact: Guoping Yang; Phone Number: +86-13974817168; Email: ygp9880@163.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Participants can communicate well with investigators, fully understand the study, volunteer to take part, comply with all study requirements, and sign written informed consent before study procedures.
2. Age 18-45 years (inclusive) at informed consent, male or female.
3. Weight ≥50.0 kg for males, ≥45.0 kg for females; BMI 19.0-26.0 kg/m² (inclusive).
4. Female participants with child-bearing potential, and male participants whose partners have child-bearing potential: no pregnancy, sperm or egg donation from consent to 3 months after last dose, and willing to use study-required contraception.
5. For MAD-only participants: receive ACYW135 meningococcal vaccine and pneumococcal vaccine at least 14 days before first dose. No re-vaccination is needed if pneumococcal vaccine was given within 5 years, or ACYW135 meningococcal vaccine within 3 years prior to first dose.

Exclusion Criteria:

1. Suspected or confirmed allergy to investigational product or its similar components; or history of multiple drug/food allergies.
2. Past history of tuberculosis infection or active tuberculosis at screening.
3. Known or suspected history of immunodeficiency, inherited or acquired complement deficiency.
4. Confirmed active systemic bacterial, viral or fungal infection within 2 weeks before screening.
5. History of confirmed encapsulated bacterial infection within 6 months before screening, including but not limited to meningococcus, streptococcus pneumoniae, Haemophilus influenzae type b.
6. Clinically significant abnormal findings in laboratory tests, physical examination, vital signs, ECG, chest X-ray or abdominal ultrasound at screening.
7. QTcF (Fridericia correction) ≥450 ms at screening; or other risk factors for torsades de pointes (TdP), such as heart failure, hypokalemia, hypomagnesemia, family history of long QT syndrome.
8. eGFR <90 mL/min/1.73 m² (calculated by CKD-EPI formula) at screening.
9. Positive for HBsAg, anti-HCV, anti-HIV or syphilis-specific antibody at screening.
10. Received other vaccines not specified in the protocol within 1 month before screening, or plan to receive such vaccines during the study.
11. Participated in another interventional clinical trial within 3 months before screening (excluding subjects who only completed screening without enrollment, or enrolled but did not receive study treatment).
12. Average daily cigarette consumption >5 cigarettes within 3 months before screening.
13. History of drug/substance abuse within 6 months before screening, or positive drug abuse screening test.
14. Chronic constipation or diarrhea, or other conditions judged by investigator to interfere with fecal sample collection.
15. Required or plan to perform heavy physical labor or strenuous exercise during study participation.
16. Pregnant or lactating women, or women of child-bearing potential with positive pregnancy test at screening.
17. Acute illness or concomitant medication occurs from screening to pre-first-dose.
18. Cannot tolerate high-fat meal (applies only to subjects in the food-effect sub-study).
19. Difficulty swallowing, intolerance to venipuncture, or history of needle-syncope or blood-syncope.
20. Investigator judges that the subject is unsuitable for this study for any other reason.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TUL321; Healthy participants take oral TUL321 capsules: Part1 single ascending doses, Part2 multiple daily doses to assess safety, tolerability, PK, PD and food effect.	Drug: Part1: TUL321; orally, 20 mg、50 mg、 100 mg、200 mg、400 mg and 600 mg; Other Names: TUL321; Drug: Part2: TUL321; orally, 50 mg QD、100 mg QD、300 mg QD、50 mg BID; Other Names: TUL321
Placebo Comparator: Placebo; Healthy participants receive oral placebo capsules matching TUL321 capsules in Part 1 and Part 2, administered in parallel with TUL321 treatment cohorts as control.	Drug: Part1: Placebo; Oral placebo capsules matching TUL321 capsules; Other Names: Placebo; Drug: Part2: Placebo; Oral placebo capsules matching TUL321 capsules; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
1.Incidence of adverse events (AEs) 2.Changes from baseline in physical examinations, vital signs, electrocardiograms (ECG), and laboratory tests	up to 17 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Peak plasma concentration (Cmax)	Pre-dose to 144 hours post-dose
Time to maximum plasma concentration (Tmax)	Pre-dose to 144 hours post-dose
Cumulative amount excreted（Ae）in urine	Pre-dose to 144 hours post-dose
Cumulative amount excreted（Ae）in feces	Pre-dose to 144 hours post-dose
Alternative pathway (AP) activity	Pre-dose to 144 hours post-dose
Bb concentration	Pre-dose to 144 hours post-dose

Collaborators and Investigators

• Sponsor: Zhuhai United Laboratories Co., Ltd.
• Investigators: Principal Investigator: Guoping Yang, The third Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2026
• Primary Completion (Estimated): May 8, 2027
• Study Completion (Estimated): May 8, 2027

Study Registration Dates

• First Submitted: August 4, 2026
• First Submitted That Met QC Criteria: August 9, 2026
• First Posted (Actual): August 12, 2026

Study Record Updates

• Last Update Posted (Actual): September 1, 2026
• Last Update Submitted That Met QC Criteria: August 30, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Bone Marrow Diseases; Anemia, Hemolytic; Anemia; Myelodysplastic Syndromes; Hemic and Lymphatic Diseases; Hemoglobinuria, Paroxysmal
• Other Study ID Numbers: TUL-TUL321（I-2）202605

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