Phase 1 Study of 3D229 in Healthy Subjects

NCT04941313 | Completed Phase 1

• 1 other identifier: 3D229-CN-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Subject

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of 3D229-Adverse events

  Monitoring of adverse events

  Up to 7 weeks

Secondary Outcomes (9)

• AUC

  Up to 7 weeks

• Cmax

  Up to 7 weeks

• Ctrough

  Up to 7 weeks

• Tmax

  Up to 7 weeks

• λz

  Up to 7 weeks

Study Arms (4)

Single Dose Escalation-3D229

EXPERIMENTAL

two sequential dose escalation cohorts - patients are randomized either to investigational drug or matching placebo

Drug: 3D229

Single Dose Escalation- placebo

PLACEBO COMPARATOR

two sequential dose escalation cohorts - patients are randomized either to investigational drug or matching placebo

Other: Placebo

Repeat Dose-3D229

EXPERIMENTAL

Four single doses of the investigational drug or matching placebo - patients are randomized either to investigational drug or matching placebo

Drug: 3D229

Repeat Dose-placebo

PLACEBO COMPARATOR

Four single doses of the investigational drug or matching placebo - patients are randomized either to investigational drug or matching placebo

Other: Placebo

Interventions

3D229 DRUG

3D229 is an investigational drug.

Repeat Dose-3D229; Single Dose Escalation-3D229

Placebo OTHER

Matching placebo

Repeat Dose-placebo; Single Dose Escalation- placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• Male or female, aged 18-55 years at the time of signing the informed consent form;
• Body mass index (BMI) between 18 and 30 kg/m 2 (Containing 18 and 30 kg/m 2 ) within range;
• Negative urine drug screen/alcohol breath test at screening and 1 day prior to first study drug administration;
• Has not used tobacco products (including nicotine patches/gum) within 3 months prior to screening and agrees to avoid such products throughout the study;
• 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
• If the subject is female, the serum pregnancy test at screening and urine pregnancy test on the day before first dose should be negative;
• Ability to fully read, understand and sign the informed consent form;
• Ability to communicate adequately with the investigator and to comply with the requirements of the entire study.

You may not qualify if:

• Blood pressure ≥ 140/90 mmHg or pulse \> 100 beats/min at rest at screening;
• QT interval corrected for heart rate using Fridericia ' s formula (QTcF) \> 430 msec (males) and \> 450 msec (females) at screening;
• Pregnant or lactating women;
• Males with partners in pregnancy;
• 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);
• Subject has a history of drug or alcohol abuse or dependence within the past 1 year;
• 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;
• 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;
• Hepatitis B virus (HBV) surface antigen, hepatitis C virus antibody (HCV), or human immunodeficiency virus (HIV) test results are currently or ever positive;
• 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);
• 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;

Sponsors & Collaborators

• 3D Medicines: lead

Study Sites (1)

Shanghai General hospital

Shanghai, Hongkou District, 201321, China

Location

Study Officials

• xueying ding

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 28, 2021
• Study Start: July 27, 2021
• Primary Completion: November 15, 2021
• Study Completion: February 21, 2022
• Last Updated: June 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)