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A Phase 1 Study to Investigate Safety, Tolerability, and Pharmacokinetics of CK-0045 in Healthy Participants and Otherwise Healthy Participants With Obesity

NCT05712876 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2024-01-10

No results posted yet for this study

Summary

The goal of this clinical trial is to assess the safety, tolerability and blood levels following a single dose or after multiple doses of CK-0045 given subcutaneously to healthy participants or otherwise healthy participants with obesity. 76 participants will receive CK-0045 or matching placebo at different escalating doses in 2 study parts: 40 healthy participants will receive a single dose and 36 otherwise healthy participants with obesity will receive 6 doses one week apart.

Conditions

  • Healthy

Interventions

DRUG

CK-0045

Interleukin-22 agonist

DRUG

Placebo

Matching placebo

Sponsors & Collaborators

  • SGS Life Sciences, a division of SGS Belgium NV

    collaborator OTHER

  • Cytoki Pharma

    lead INDUSTRY

Principal Investigators

  • Anne Louise Kjølbye, PhD · Cytoki Pharma

  • Lotte Verwillingen, MD · SGS Clinical Research, Clinical Pharmacology Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-26
Primary Completion
2024-01-04
Completion
2024-01-04

Countries

  • Belgium

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05712876 on ClinicalTrials.gov