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

ConditionHealthy Participants
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorTangram Therapeutics Plc

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • TGM-148

    Drug

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

  • Placebo

    Drug

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: TGM-148Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Frequency and severity of adverse events [Safety and tolerability]

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

Secondary outcomes

1

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.

Time frame
From start of study drug administration through 48 hours after the last study drug administration.
2

Maximum observed plasma concentration (Cmax) of TGM-148 (ng/mL)

Maximum observed plasma concentration derived from plasma concentration-time data.

Time frame
From start of study drug administration through 48 hours after study drug administration.
3

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

Time of maximum observed plasma concentration derived from plasma concentration-time data.

Time frame
From start of study drug administration through 48 hours after study drug administration.
4

Half life (T½) of TGM-148

Half life derived from plasma concentration-time data.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tangram Therapeutics Plc

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: