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To Evaluate the Safety, Tolerability, and Pharmacokinetics After Subcutaneous Administration of C1K in Healthy Subjects

NCT05980065 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2023-12-04

No results posted yet for this study

Summary

A dose-block randomized, double-blind, placebo-controlled, single and multiple ascending dose, first-in-human, phase 1 first in human clinical trial to evaluate the safety, tolerability, and pharmacokinetics after subcutaneous administration of C1K in healthy Korean subjects.

Conditions

  • Healthy Subjects

Interventions

DRUG

C1K

Subcutaneously administrate C1K 150mg at 0 Day 1, Day 8, Day 15

DRUG

C1K

Subcutaneously administrate C1K 300mg at 0 Day 1, Day 8, Day 15

DRUG

Placebo

Subcutaneously administrate placebo at 0 Day 1, Day 8, Day 15

DRUG

C1K

Subcutaneously administrate C1K 600mg at 0 Day 1, Day 8, Day 15

DRUG

C1K

Subcutaneously administrate C1K 900mg at 0 Day 1, Day 8, Day 15

DRUG

C1K

Subcutaneously administrate C1K 1200mg at 0 Day 1, Day 8, Day 15

Sponsors & Collaborators

  • Ensol Biosciences, Inc.

    collaborator UNKNOWN

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • JAESEONG OH · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-20
Primary Completion
2023-06-13
Completion
2023-10-04

Countries

  • South Korea

Study Locations

More Related Trials

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 NCT05980065 on ClinicalTrials.gov