A Randomized, Double-blind, Placebo-controlled, Multiple Doses, Dose-escalation Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SRN001 in Healthy Korean and Caucasian Adult Males

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of repeated doses of SRN001 in healthy adult volunteers.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 19
Maximum Age: 60
Healthy Volunteers: t
View:

• Healthy Korean or Caucasian male volunteers aged 19 to 60 years at the time of screening.

• Those who weighed 50.0 kg or more at the time of screening and had a body mass index (BMI) between 18.5 kg/m2 and 29.9 kg/m2.

• Body mass index (BMI, kg/m2) = weight (kg) / {height (m2)} 2

• Those whose screening results showed a serum amphiregulin concentration of 100 pg/mL or higher.

• Those who voluntarily agreed to participate in this clinical trial after receiving a thorough explanation and fully understanding the clinical trial. Those who decided to participate and gave written consent to comply with the precautions.

Locations
Other Locations
Republic of Korea
Seoul National University Hospital
RECRUITING
Seoul
Contact Information
Primary
Eunkyeong Woo
wek@sirnagen.com
+82-42-930-8654
Time Frame
Start Date: 2026-01-05
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 30
Treatments
Experimental: cohort1 Drug: SRN001 45mg
cohort1 Drug: SRN001 45mg
Experimental: cohort2 Drug: SRN001 90mg
cohort2 Drug: SRN001 90mg
Experimental: cohort3 Drug: SRN001 180mg
cohort3 Drug: SRN001 180mg
Placebo_comparator: Placebo Comparator
Participants receive placebo (0.9% sodium chloride, normal saline)
Sponsors
Leads: siRNAgen Therapeutics Inc.

This content was sourced from clinicaltrials.gov