Safety, Tolerability, PK, and PD of TGM-148 in Healthy Participants

NCT07843368 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: TGM-148-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• Frequency and severity of adverse events [Safety and tolerability]

  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)

  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)

  From start of study drug administration through 48 hours after study drug administration.

• Time of maximum plasma concentration (Tmax) of TGM-148

  From start of study drug administration through 48 hours after study drug administration.

• Half life (T½) of TGM-148

  From start of study drug administration through 48 hours after study drug administration.

• Change from baseline in target biomarker levels in plasma

  From start of study drug administration through 16 weeks after study drug administration.

Study Arms (2)

TGM-148

EXPERIMENTAL

Participants will receive study treatment according to the assigned intervention.

Drug: TGM-148

Placebo

PLACEBO COMPARATOR

Participants will receive placebo according to the assigned intervention.

Drug: Placebo

Interventions

TGM-148 DRUG

TGM-148 is an investigational medicinal product administered by subcutaneous injection according to a protocol-defined regimen.

TGM-148

Placebo DRUG

Placebo administered by subcutaneous injection according to a protocol-defined regimen.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tangram Therapeutics Plc: lead

Study Sites (1)

Hammersmith Medicines Research

London, United Kingdom

Location

Study Officials

• Sponsor Medical Representative

  Tangram Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Sponsor Clinical Trials Office

CONTACT

+44 20 4558 3826; clinicaltrials@tangramtx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 28, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)