Study of CM583 in Healthy Participants

Phase 1Not Yet RecruitingNCT07823764

Keymed Biosciences Co.Ltd40 enrolled

Overview

This is a randomized, double-blind, placebo-controlled, single-ascending-dose Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM583 in healthy adult participants. Approximately 40 participants will be enrolled in five dose cohorts. Within each cohort, participants will be randomized in a 3:1 ratio to receive a single subcutaneous dose of CM583 or placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

CM583BIOLOGICAL

CM583 injection administered SC(Subcutaneous), once

PlaceboDRUG

Placebo injection administered SC, once

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects age ≥ 18 years \& ≤45 years. * Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol. Exclusion Criteria: * The average number of cigarettes smoked per day is greater than 5 within 3 months prior to screening. * Drinking heavily within 3 months prior to screening, or unable to guarantee not to drink alcohol during the research period, or positive alcohol breath testing. * History of drug abuse within 1 year prior to screening, or positive urine drug abuse screening. * Blood donation or any other form of blood loss exceeding 400mL, or accepting blood transfusion within 12 weeks prior to screening. * Suspected allergy to CGRP(Calcitonin Gene-Related Peptide)- or PACAP(Pituitary Adenylate Cyclase-Activating Polypeptide)-targeting antibody drugs, humanized monoclonal antibody drugs and their excipients, or other biological agents, or have a history of severe allergic reactions to other drugs. * Severe trauma or undergo major surgery within 3 months prior to screening, or planned surgery during the research period.

Locations (1)

The Second Affiliated Hospital Zhejiang University School of Medcine

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

TEAEs will be coded using Medical Dictionary for Regulatory Activities(MedDRA) and summarized by System Organ Class and Preferred Term. Serious, severe, treatment-related, fatal TEAEs and TEAEs leading to study withdrawal will also be summarized.