Healthy VolunteersEarly Phase 1NCT04559971
A Phase 1 Study to Evaluate the Safety, Tolerability, PK and PD of SLN124 in Healthy Volunteers
A Early Phase 1 study testing SLN124 in people with Healthy Volunteers, run by Silence Therapeutics plc at 1 site in United Kingdom.
Trial summary
This study will evaluate the safety and tolerability of SLN124 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- SLN124
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Sep 2020to 23 Mar 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
This study will evaluate the safety and tolerability of SLN124 in healthy volunteers.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- SLN124, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLN124Drug
SLN124 for subcutaneous (s.c.) injection
PlaceboDrug
Sodium chloride for s.c. injection
| Study group | Role | What they receive |
|---|---|---|
| 1.0mg/kg | Experimental | Drug: SLN124 Receives: Drug: SLN124 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| 3.0mg/kg | Experimental | Drug: SLN124 Receives: Drug: SLN124 |
| Optional Cohort | Experimental | An additional dose level may be explored Receives: Drug: SLN124 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
safety and tolerability
Measured: 8 weeks
Secondary outcomes (3)
Pharmacokinetic: peak plasma concentration (Cmax)
Measured: 7 days
Pharmacokinetic: area under the plasma concentration (AUC)
Measured: 7 days
Pharmacokinetic: apparent total clearance from plasma after s.c injection (CL/F)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start3 Sep 2020
- Primary completion23 Mar 2021
- Study completion23 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silence Therapeutics plc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giles Campion, MD, Study director, Silence Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559971
- Sponsor's protocol ID
- SLN124-003
- Status last verified
- Apr 2023
- First submitted
- 8 Sep 2020
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Porter JB, Scrimgeour A, Martinez A, James L, Aleku M, Wilson R, Muckenthaler M, Boyce M, Wilkes D, Schaeper U, Campion GV. SLN124, a GalNAc conjugated 19-mer siRNA targeting tmprss6, reduces plasma iron and increases hepcidin levels of healthy volunteers. Am J Hematol. 2023 Sep;98(9):1425-1435. doi: 10.1002/ajh.27015. Epub 2023 Jul 27.
PubMed 37497888
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04559971
- Acronym / sponsor ID
- SLN124-003
- Conditions
- Healthy Volunteers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Silence Therapeutics plcIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 23 Mar 2021 (actual)
- Study completion
- 23 Mar 2021 (actual)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and tolerability of SLN124 in healthy volunteers.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1.0mg/kg | Experimental | Drug: SLN124Drug: SLN124 |
| Placebo | Placebo comparator | Drug: Placebo |
| 3.0mg/kg | Experimental | Drug: SLN124Drug: SLN124 |
| Optional Cohort | Experimental | Drug: SLN124An additional dose level may be explored |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SLN124SLN124 for subcutaneous (s.c.) injection | Drug | 1.0mg/kg, 3.0mg/kg, Optional Cohort |
| PlaceboSodium chloride for s.c. injection | Drug | Placebo |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: 8 weeks
safety and tolerability
3 secondary outcomes
Pharmacokinetic: peak plasma concentration (Cmax)
Time frame: 7 days
Pharmacokinetic: area under the plasma concentration (AUC)
Time frame: 7 days
Pharmacokinetic: apparent total clearance from plasma after s.c injection (CL/F)
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Derived from this study: PubMed 37497888Porter JB, Scrimgeour A, Martinez A, James L, Aleku M, Wilson R, Muckenthaler M, Boyce M, Wilkes D, Schaeper U, Campion GV. SLN124, a GalNAc conjugated 19-mer siRNA targeting tmprss6, reduces plasma iron and increases hepcidin levels of healthy volunteers. Am J Hematol. 2023 Sep;98(9):1425-1435. doi: 10.1002/ajh.27015. Epub 2023 Jul 27.
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giles Campion, MD study director
Silence Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing SLN124 in people with Healthy Volunteers, run by Silence Therapeutics plc at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04559971, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.