A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Characteristics of a Single Subcutaneous Administration of IBI3040 in Healthy Participants and Multiple Subcutaneous Administrations in Overweight or Obese Participants

Registration

Registration

NCT07765160

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

DOUBLE

Status

NOT_YET_RECRUITING

Enrollment

96

Start

2026-08-30

Primary completion

2027-11-10

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Conditions

Healthy Participants; Overweight or Obese Participants

Interventions

DRUG:SAD: subcutaneous injection in the abdomen; DRUG:MAD: subcutaneous injection in the abdomen

Results posted

FALSE

Registered primary outcomes

• SAD: The incidence rate of adverse events (AE) [through study completion, an average of 60 days]
• SAD: The incidence rate of serious adverse events (SAE) [through study completion, an average of 60 days]
• SAD: Number of subjects with clinically significant changes in physical examination results [through study completion, an average of 60 days]
• SAD: Number of subjects with clinically significant changes in vital signs [through study completion, an average of 60 days]
• SAD: Number of participants with abnormal laboratory tests results [through study completion, an average of 60 days]
• SAD: Number of subjects with clinically significant changes in twelve-lead electrocardiogram [through study completion, an average of 60 days]
• MAD: The incidence rate of adverse events (AE) [through study completion, an average of 20 weeks]
• MAD: The incidence rate of serious adverse events (SAE) [through study completion, an average of 20 weeks]
• MAD: Number of subjects with clinically significant changes in physical examination results [through study completion, an average of 20 weeks]
• MAD: Number of subjects with clinically significant changes in vital signs [through study completion, an average of 20 weeks]
• MAD: Number of participants with abnormal laboratory tests results [through study completion, an average of 20 weeks]
• MAD: Number of subjects with clinically significant changes in twelve-lead electrocardiogram [through study completion, an average of 20 weeks]