The First-in-human Study of SRN-001 in Healthy Participants

NCT05984992 | Completed Phase 1

• 1 other identifier: SRN-001-C01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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 factor involved in fibroblast proliferation and myofibroblast transformation which is the hallmark of fibrosis in lung and kidney tissues. AREG is a downstream gene overexpressed by Transforming growth factor-β (TGF-β) during fibrosis, promoting fibroblast to myofibroblast transition (FMT). SRN-001 is designed to downregulate generating amphiregulin by RNA interference (RNAi). The goal of this clinical trial is to evaluate safety, tolerability, and pharmacokinetics in healthy participants. This trial is first-in-human clinical trial to develop SAMiRNA™ to utilize as therapeutic use.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (2)

• Number of participants with treatment-emergent adverse events(TEAEs)

  Up to 4 weeks

• Number of participants with serious adverse events(SAEs)

  Up to 4 weeks

Secondary Outcomes (10)

• Cmax

  Up to 168 hours post-dose

• Clast

  Up to 168 hours post-dose

• Tlast

  Up to 168 hours post-dose

• AUClast

  Up to 168 hours post-dose

• AUCinf

  Up to 168 hours post-dose

Other Outcomes (2)

• Incidence of treatment-emergent Anti-Drug Antibody(ADA)

  Up to 672 hours post-dose

• Change from baseline in specific biomarkers

  Up to 24 hours post-dose

Study Arms (2)

SRN-001

EXPERIMENTAL

Drug: SRN-001

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SRN-001 DRUG

siRNA therapeutics, Self Assembled Micelle inhibitory RNA platform utilized

SRN-001

Placebo DRUG

0.9% Sodium Chloride(Normal saline)

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70
• BMI ≥18.0 kg/㎡ and ≤35 kg/㎡
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• siRNAgen Therapeutics Inc.: lead

Study Sites (1)

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

Location

Related Publications (1)

• Gleason DF, Mellinger GT. Prediction of prognosis for prostatic adenocarcinoma by combined histological grading and clinical staging. J Urol. 1974 Jan;111(1):58-64. doi: 10.1016/s0022-5347(17)59889-4. No abstract available.

  PMID: 4813554 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Design

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

Model Details: Randomized, Double-blinded, Placebo-controlled, Single Ascending Dose

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 9, 2023
• Study Start: September 8, 2023
• Primary Completion: March 15, 2024
• Study Completion: September 25, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)