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

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

August 18, 2025

Primary Completion Date

May 20, 2027

Study Completion Date

August 20, 2027

Conditions
Healthy Postmenopausal Women
Interventions
DRUG

experimental Arm IMC-003

"Part 1: Single Dose Dose Escalation (SAD):~Dose and frequency: 0.03mg/kg, 0.1mg/kg, 0.3mg/kg, 0.7mg/kg, 1.0mg/kg for single administration, with the test drug or placebo administered respectively.~Part 2: Multiple Dose Dose Escalation (MAD):~Dose and frequency: Tentatively set at 0.3mg/kg, 0.5mg/kg, 0.7mg/kg. Administer once every 3 weeks 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.

All Listed Sponsors
lead

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

OTHER