Clinically studied UK GMP Launch preparation

Clinical study · Evidence in progress

Rigorousclinical researchin healthy adults.

A 12-month clinical phase within a four-year T-Booster R&D programme, involving 260 adults across two randomised, double-blind studies with placebo and dose comparisons.

4 YEARST-BOOSTER R&D PROGRAMME
12 MONTHSCLINICAL RESEARCH PHASE
2 STUDIESRANDOMISED, DOUBLE-BLIND
260HEALTHY ADULTS

01 · Programme architecture

One programme.Two clinical studies.

A 12-month controlled clinical phase within the wider four-year T-Booster R&D programme involved 260 healthy adults at BSMMU, Dhaka.

Clinical study participants and staff at the study site
01
Study design

Randomised and double-blind.

02
Comparators

Placebo and dose comparisons.

03
Assessment points

Baseline and four-month assessments.

04
Study site

BSMMU, Dhaka.

02 · Participant pathway

From screening to scientific interpretation.

The same sequence was used across the programme so baseline and four-month assessments could be compared consistently.

  1. 01

    Screening and consent

    Eligibility review and written informed consent before enrolment.

  2. 02

    Randomisation

    Blinded allocation to T-Booster or placebo.

  3. 03

    Baseline assessment

    Blood sample and lifestyle questionnaire.

  4. 04

    Four-month intervention

    Daily assigned capsules with blinded follow-up.

  5. 05

    End assessment

    Repeat blood sample and questionnaire.

  6. 06

    Scientific analysis

    Group comparison, statistics and reporting.

6 mL blood collected at baseline and at the end of the study

03 · Evidence framework

Three evidence streams, interpreted together.

The programme combined biological measurement with participant-reported experience. Each stream answers a different question and adds context to the others.

01

Thymic output

TREC DNA

An indirect marker associated with newly generated T-cell output.

02

Blood context

CBC and lymphocytes

Wider blood measures provide biological context for the analysis.

03

Participant experience

Lifestyle questionnaire

Repeated questionnaires captured changes participants noticed in everyday wellbeing.

04 · Preliminary age analysis

TREC DNA increasedin every age group.

The largest observed increase occurred among participants aged 48–57, while placebo remained close to baseline across every age group.

TREC DNA · copies/µL blood

Baseline, placebo and T-Booster after four months

Baseline Placebo T-Booster
Preliminary age-group analysis. Final statistical interpretation, publication and peer review remain in progress.

05 · Participant-reported outcomes

Improvement ratesby concern.

The percentages below refer only to participants who reported that specific concern at baseline. They show the proportion of that subgroup who reported improvement at the four-month assessment.

50total questions
18lifestyle questions
8reported areas

Base: participants reporting each concern at baseline

Sleep80%
Urinary76%
Energy75%
Mood75%
Sexual75%
Pain73%
Skin68%
Stress48%

These are participant-reported outcomes from baseline-defined subgroups and provide context; they should not be interpreted as proof of clinical effect.

06 · The programme on film

Two perspectives on the programme.

One film explains the research programme in public; the other records participant perspectives from inside the study.

The films document the programme and participant experience; they are not evidence of clinical effect.

The next chapter

From evidence to commercial readiness.

Explore the commercial pathway and preparations for market entry.

View commercial opportunity