Phase 1 Study of 3D229 in Healthy Subjects

A Single-blind, Randomized, and Placebo-Controlled Phase 1 Study to Evaluate the Safety and Tolerability of 3D-229 by Intravenous Single Dose Escalation and Repeated Doses in Healthy Subjects

This is a Phase 1 Study to Evaluate the Safety and tolerability of 3D-229 in health subjects

Study Overview

• Status: Completed
• Conditions: Healthy Subject
• Intervention / Treatment: Other: Placebo; Drug: 3D229

Detailed Description

A Single-blind, Randomized, and Placebo-Controlled Phase 1 Study to Evaluate the Safety and tolerability of 3D-229 by Intravenous Single Dose Escalation(SAD) and Repeated Doses(RD) in Healthy Subjects. A SAD portion of the study consists of 2 sequential dose escalation cohorts, whereas RD portion of the study consists of a single cohort receiving 4 weekly doses of 3D229. In both SAD and RD study arms, subjects are randomized to receive either a study intervention (3D229) or matching placebo.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hongkou District
    • Shanghai, Hongkou District, China, 201321
      • Shanghai General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy subjects had no clinically significant condition or disease confirmed by medical history, medical assessment, physical examination, clinical laboratory tests, and 12-lead electrocardiogram (ECG) at screening and on the day prior to the first study drug administration;
2. Male or female, aged 18-55 years at the time of signing the informed consent form;
3. Body mass index (BMI) between 18 and 30 kg/m 2 (Containing 18 and 30 kg/m 2 ) within range;
4. Negative urine drug screen/alcohol breath test at screening and 1 day prior to first study drug administration;
5. Has not used tobacco products (including nicotine patches/gum) within 3 months prior to screening and agrees to avoid such products throughout the study;
6. Complete abstinence for at least 14 days prior to the first dose of study drug and Take effective contraceptive measures within 3 months after the last dose(including Complete abstinence、 barrier contraception and completed sterilization operation), no fertility, sperm donation, egg donation program
7. If the subject is female, the serum pregnancy test at screening and urine pregnancy test on the day before first dose should be negative;
8. Ability to fully read, understand and sign the informed consent form;
9. Ability to communicate adequately with the investigator and to comply with the requirements of the entire study.

Exclusion Criteria:

1. Blood pressure ≥ 140/90 mmHg or pulse > 100 beats/min at rest at screening;
2. QT interval corrected for heart rate using Fridericia ' s formula (QTcF) > 430 msec (males) and > 450 msec (females) at screening;
3. Pregnant or lactating women;
4. Males with partners in pregnancy;
5. Concurrently enrolled in another clinical trial, or received any study drug within 3 months prior to the first dose (or 5 drug half-lives, whichever is longer);
6. Subject has a history of drug or alcohol abuse or dependence within the past 1 year;
7. Use of any prescription or over-the-counter medications, including analgesics, hormonal contraceptives (oral contraceptives or implanted contraceptives), natural food supplements, or dietary/herbal supplements (including vitamins), 14 days or 5 drug half-lives, whichever is longer;
8. Donation of more than 200 mL of blood within 56 days prior to the first dose, or planned to donate blood during the study until 1 month after completion of the study;
9. Hepatitis B virus (HBV) surface antigen, hepatitis C virus antibody (HCV), or human immunodeficiency virus (HIV) test results are currently or ever positive;
10. Prior or current condition that, in the opinion of the investigator, may affect the conduct of the study or observations (to be confirmed by medical history);
11. History or current patient ' s clinically significant disease,Including but not limited to: active tuberculosis, asthma, angioedema, bronchospasm, ulcerative disease, gastrointestinal hemorrhage, coagulation disorder, hypertension, edema, heart failure, hypokalemia, hyperkalemia, cardiovascular disease, hypersensitivity to any biological agent, and significant impact on immune responseSevere skin diseases or other conditions of the force;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Dose Escalation-3D229; two sequential dose escalation cohorts - patients are randomized either to investigational drug or matching placebo	Drug: 3D229; 3D229 is an investigational drug.
Placebo Comparator: Single Dose Escalation- placebo; two sequential dose escalation cohorts - patients are randomized either to investigational drug or matching placebo	Other: Placebo; Matching placebo
Experimental: Repeat Dose-3D229; Four single doses of the investigational drug or matching placebo - patients are randomized either to investigational drug or matching placebo	Drug: 3D229; 3D229 is an investigational drug.
Placebo Comparator: Repeat Dose-placebo; Four single doses of the investigational drug or matching placebo - patients are randomized either to investigational drug or matching placebo	Other: Placebo; Matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability of 3D229-Adverse events	Monitoring of adverse events	Up to 7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC	Area under the curve	Up to 7 weeks
Cmax	Maximum observed concentration	Up to 7 weeks
Ctrough	Serum concentration observed at end of a single dose and observed pre-dose during repeat doses	Up to 7 weeks
Tmax	Time to reach maximum observed plasma concentration	Up to 7 weeks
λz	Terminal phase elimination rate constant	Up to 7 weeks
t1/2	Terminal half-life	Up to 3 weeks
CL	The total body clearance	Up to 7 weeks
V	Volume of distribution	Up to 7 weeks
serum GAS6	evaluate the serum GAS6 level	Up to 7 weeks

Collaborators and Investigators

• Sponsor: 3D Medicines
• Investigators: Principal Investigator: xueying ding, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2021
• Primary Completion (Actual): November 15, 2021
• Study Completion (Actual): February 21, 2022

Study Registration Dates

• First Submitted: May 31, 2021
• First Submitted That Met QC Criteria: June 19, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 20, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 3D229-CN-001

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: No
• Studies a U.S. FDA-regulated device product: No