Status:
COMPLETED
The First-in-human Study of SRN-001 in Healthy Participants
Lead Sponsor:
siRNAgen Therapeutics Inc.
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
SRN-001 is a novel small interfering RNA (siRNA) drug being developed to treat fibrosis using Self Assembled Micelle inhibitory ribonucleic acid (SAMiRNA™) technology. Amphiregulin (AREG) is a growth ...
Detailed Description
Participants with part in consent will be enrolled in a phase 1a study of SRN-001. Prior to initiation of treatment, participants will undergo several screening test for checking their condition of he...
Eligibility Criteria
Inclusion
- Age 18-70
- BMI ≥18.0 kg/㎡ and ≤35 kg/㎡
- 12-lead triplicate electrocardiogram (ECG) readings within normal limits or with no clinically significant abnormalities
- systolic blood pressure ≥ 90 mmHg and ≤160 mmHg; a diastolic blood pressure ≥ 50 mmHg and ≤95 mmHg; pulse ≥ 45 bpm and ≤100 bpm; tympanic temperature ≥ 35.5°C and ≤37.7°C and respiratory rate 12rpm to 22rpm
- Negative urinary cotinine
- Compliance to contraception and sperm donation restriction
- Participants who are able and willing to give written informed consent
- Fully vaccinated against SARS-CoV-2
Exclusion
- Who has clinically significant history
- Who is with history of multiple drug allergies or history of allergic reaction to an oligonucleotide or common medicine (eg, aspirin, antibiotics, etc) or clinically significant hypersensitivity
- No tolerance to IV injections or significant potential of intolerance
- Clinically significant surgical history within 1 year
- History of drug abuse or alcoholism within 2 years, and a restriction of consuming alcohol during study period
- Pregnant or lactating females
- Liver function test is 1.5 times greater than upper limit of normal (ULN)
- Albumin ≥ 35 g/L and ≤ 50 g/L
- Hb \< 115 g/L (female), \< 125 g/L (male)
- estimated glomerular filtration rate (eGFR) \< 60 mL/min (CKD-EPI), 90 mL/min (MDRD)
- Glucose \< 3 mmol/L
- Positive screen for alcohol or drugs of abuse
- HBsAg, Hepatitis B virus (HBV), Hepatitis C virus (HCV), or HIV infection
- QTcF \> 450 msec for male, \> 470 msec for female
- Inappropriate lab result by physician's discretion
- Who have donated \> 500 mL of blood within 3 months
- Who have received an investigational agent within 3 months, or 5 half-lives
- Who have used prescription medication within 4 weeks including vaccines
- Who have used OTC medication within 7 days
- With clinically relevant wounds, following a clinically relevant surgery or have recently completed any invasive procedures (ie, Endoscopy) within 1 week, or who are scheduled for an elective surgical procedure
- Who have a significant infection or known inflammatory process ongoing
- Any conditions that, in physician's opinion, would make the participant unsuitable for enrollment or could interfere with the participant's participation
Key Trial Info
Start Date :
September 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05984992
Start Date
September 8 2023
End Date
September 25 2024
Last Update
November 4 2024
Active Locations (1)
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1
CMAX Clinical Research
Adelaide, South Australia, Australia, 5000