NCT06161090

Brief Summary

This is a single center, randomized, double-blind, placebo-controlled, dose escalation study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2020

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
Last Updated

December 7, 2023

Status Verified

November 1, 2023

Enrollment Period

4 months

First QC Date

November 29, 2023

Last Update Submit

November 29, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Adverse event

    Incidence of adverse events.

    up to Week 9

Study Arms (5)

Group 75 mg

EXPERIMENTAL

CM310 Recombinant Humanized Monoclonal Antibody Injection

Biological: CM310

Group 150 mg

EXPERIMENTAL

CM310 Recombinant Humanized Monoclonal Antibody Injection

Biological: CM310

Group 300 mg

EXPERIMENTAL

CM310 Recombinant Humanized Monoclonal Antibody Injection

Biological: CM310

Group 600 mg

EXPERIMENTAL

CM310 Recombinant Humanized Monoclonal Antibody Injection

Biological: CM310

Placebo

PLACEBO COMPARATOR

Placebo, Subcutaneous

Drug: Placebo

Interventions

CM310BIOLOGICAL

CM310 injection

Group 150 mgGroup 300 mgGroup 600 mgGroup 75 mg
PlaceboDRUG

subcutaneous injection

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male volunteers.
  • aged ≥ 18 and ≤ 65 years old.
  • With all clinical laboratory examination normal.
  • Voluntary signing of the informed consent form.

You may not qualify if:

  • With a history of asthma and allergic reactions.
  • With a history of conjunctivitis and keratitis, as well as previous medical conditions.
  • With positive results from alcohol breath or urine drug abuse testing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PKUCare Luzhong Hospital

Zibo, China

Location

Related Publications (1)

  • Zhang L, Zhang W, Xu Y, Dong L, Sun Y, Jia Y, Li Z, Chen B, Hou J, Zhang J. Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Stapokibart in Healthy Volunteers and Adult Subjects with Atopic Dermatitis. Adv Ther. 2024 Jul;41(7):2953-2965. doi: 10.1007/s12325-024-02887-w. Epub 2024 Jun 4.

    PMID: 38833140DERIVED

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2023

First Posted

December 7, 2023

Study Start

September 3, 2019

Primary Completion

January 13, 2020

Study Completion

January 13, 2020

Last Updated

December 7, 2023

Record last verified: 2023-11

Locations

CN(1)