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RECRUITING
NCT07118085
PHASE1

A Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IMC-003 for Injection in Healthy Postmenopausal Women

Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

View on ClinicalTrials.gov

Summary

this study is a randomized, double-blind, placebo-controlled, single and multiple dose escalation Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IMC-003 for injection in healthy postmenopausal women.

Key Details

Gender

FEMALE

Age Range

45 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2025-08-18

Completion Date

2027-08-20

Last Updated

2025-12-15

Healthy Volunteers

Yes

Interventions

DRUG

experimental Arm IMC-003

Part 1: Single Dose Dose Escalation (SAD): single administration, with the test drug or placebo administered respectively. Part 2: Multiple Dose Dose Escalation (MAD): Administer for 5 consecutive times (unless the subject cannot tolerate, withdraw prematurely, or is lost to follow-up, etc.), with the test drug or placebo administered respectively.

DRUG

The placebo Arm: The placebo of IMC-003

Part 1(SAD) subject will receive IMC-003 once ; Part 2 (MAD) subject will receive the placebo of IMC-003 for 5 times, with an interval of 21 days between each administration.

Locations (1)

Chengdu Xinhua hospital

Chengdu, Sichuan, China