Healthy ParticipantsPhase 1NCT07843368
Safety, Tolerability, PK, and PD of TGM-148 in Healthy Participants
A Phase 1 study testing TGM-148 in people with Healthy Participants, run by Tangram Therapeutics Plc at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) effects of single ascending doses of TGM-148 in healthy adults Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- TGM-148
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Oct 2026to Mar 2028
- Phase
- Phase 1
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 18 to 45 years who are able to provide written informed consent.
- Medically suitable for study participation based on protocol-defined assessments.
- Body mass index (BMI) between 18.0-30.0 kg/m² (inclusive) and a body weight >50 kg.
Who cannot join
- Clinically significant medical conditions, laboratory abnormalities, or other findings that, in the opinion of the investigator, could increase risk, interfere with study participation, or confound interpretation of study results.
- Recent participation in another investigational study.
- Use of medications that are prohibited by the protocol.
- Any other condition that would make the individual unsuitable for study participation as determined by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Hammersmith Medicines Research
London
About this study
Official title: A First-in-human, Randomised, Double-masked (Sponsor Unmasked), Placebo-controlled, Parallel Group, Single Ascending Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Dose of TGM-148 in Healthy Participants
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) effects of single ascending doses of TGM-148 in healthy adults
Read the detailed description
This trial is a Phase 1, FIH, randomised, double-masked (sponsor unmasked), placebo-controlled, parallel-group, single ascending dose trial designed to evaluate the safety, tolerability, PK, and PD of a single SC dose of TGM-148 in healthy participants.
- Conditions
- Healthy Participants
- Being tested
- TGM-148, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TGM-148Drug
TGM-148 is an investigational medicinal product administered by subcutaneous injection according to a protocol-defined regimen.
PlaceboDrug
Placebo administered by subcutaneous injection according to a protocol-defined regimen.
| Study group | Role | What they receive |
|---|---|---|
| TGM-148 | Experimental | Participants will receive study treatment according to the assigned intervention. Receives: Drug: TGM-148 |
| Placebo | Placebo comparator | Participants will receive placebo according to the assigned intervention. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of adverse events [Safety and tolerability]
Measured: From start of study drug administration through 16 weeks after study drug administration.
Secondary outcomes (5)
Area under the plasma concentration-time curve (AUC) of TGM-148 (ng·h/mL)
Area under the plasma concentration-time curve derived from plasma concentration-time data.
Measured: From start of study drug administration through 48 hours after the last study drug administration.
Maximum observed plasma concentration (Cmax) of TGM-148 (ng/mL)
Maximum observed plasma concentration derived from plasma concentration-time data.
Measured: From start of study drug administration through 48 hours after study drug administration.
Time of maximum plasma concentration (Tmax) of TGM-148
Time of maximum observed plasma concentration derived from plasma concentration-time data.
Measured: From start of study drug administration through 48 hours after study drug administration.
Half life (T½) of TGM-148
Half life derived from plasma concentration-time data.
Measured: From start of study drug administration through 48 hours after study drug administration.
Change from baseline in target biomarker levels in plasma
Change from baseline in target biomarker levels in plasma samples following administration of TGM-148, expressed as concentration or relative change from baseline.
Measured: From start of study drug administration through 16 weeks after study drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start16 Oct 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tangram Therapeutics Plc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sponsor Medical Representative, Study director, Tangram Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843368
- Sponsor's protocol ID
- TGM-148-001
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study results will be disseminated through publication