A Phase 1 Study to Evaluate the Safety, Tolerability, PK and PD of SLN124 in Healthy Volunteers

• Sponsor: Silence Therapeutics plc (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04559971
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 8.9
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief Summary

This study will evaluate the safety and tolerability of SLN124 in healthy volunteers.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: SLN124; Drug: Placebo	Early Phase 1

Detailed Description

This first-in-human (FIH) study will investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SLN124 after single ascending s.c. doses in healthy male and female subjects.

Up to 3 cohorts of 24 healthy volunteers will be enrolled. Each subject will receive a single dose of SLN124 or placebo given by subcutaneous (s.c) injection.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomised, Double-blind, Placebo-controlled Phase 1 Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered SLN124 in Healthy Volunteers
• Actual Study Start Date: Sep 3, 2020
• Anticipated Primary Completion Date: Jun 1, 2021
• Anticipated Study Completion Date: Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1.0mg/kg Drug: SLN124	Drug: SLN124; SLN124 for subcutaneous (s.c.) injection
Placebo Comparator: Placebo	Drug: Placebo; Sodium chloride for s.c. injection
Experimental: 3.0mg/kg Drug: SLN124	Drug: SLN124; SLN124 for subcutaneous (s.c.) injection
Experimental: Optional Cohort An additional dose level may be explored	Drug: SLN124; SLN124 for subcutaneous (s.c.) injection

Outcome Measures

Primary Outcome Measures

1. Incidence of treatment-emergent adverse events [8 weeks]

   safety and tolerability

Secondary Outcome Measures

1. Pharmacokinetic: peak plasma concentration (Cmax) [7 days]

2. Pharmacokinetic: area under the plasma concentration (AUC) [7 days]

3. Pharmacokinetic: apparent total clearance from plasma after s.c injection (CL/F) [7 days]

Other Outcome Measures

1. Pharmacodynamic: change in ferritin [8 weeks]

2. Pharmacodynamic: change in TSAT [8 weeks]

3. Pharmacodynamic: change in hepcidin [8 weeks]

4. Pharmacodynamic: change in haemoglobin [8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Normotensive male or female volunteers, with a body mass index of 18.0-30.0 kg/m2.

• Deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine.

• Agree to follow the contraception requirements of the trial.

• Able to give fully informed written consent.

• Agree not to donate blood or blood products during the study and for up to 3 months after the administration of the trial medication.

Exclusion Criteria:

• History or presence of iron deficiency or iron deficiency anaemia and/or currently receiving oral or parenteral iron supplementation as treatment for those conditions.

• Positive tests for hepatitis B & C, HIV

• Drug or alcohol abuse.

• Smoke more than 10 cigarettes (or equivalent) daily.

• Use of over-the-counter medication (with the exception of paracetamol [acetaminophen]) during the 7 days before the first dose of trial medication, or prescribed medication (with the exception of hormone replacement therapy [HRT]) during the 28 days before first dose of trial medication.

• Use of supplement(s) during the 28 days before screening.

• Participation in other clinical trials of unlicensed medicines, or loss of more than 400 mL blood, within the previous 3 months.

• Clinically relevant abnormal medical history or concurrent medical condition.

• Pre-menopausal females who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hammersmith Medicines Research	London		United Kingdom

Sponsors and Collaborators

• Silence Therapeutics plc

Investigators

• Study Director: Giles Campion, MD, Silence Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Silence Therapeutics plc
• ClinicalTrials.gov Identifier: NCT04559971
• Other Study ID Numbers: SLN124-003
• First Posted: Sep 23, 2020
• Last Update Posted: Mar 5, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 5, 2021