phase I
enrolling now

The Needle-Free Medicine Study

For healthy adults aged 18–45 in good general health with a BMI between 18.0 and 32.0. Conducted at our Maroochydore clinic on the Sunshine Coast.
Age 18-45
day and overnight
Up to $9700
About this trial

Testing a needle-free way to deliver medicine

Right now, nearly 180,000 Australians are living with a disease most people have never heard of, and it's growing faster here than almost anywhere else in the world. Inflammatory bowel disease (IBD) is climbing at a rate that already outpaces Canada, the UK and New Zealand, while psoriasis affects an estimated 3.68% of adults in the Australasia region, among the highest rates in the world according to the Global Psoriasis Atlas. Both conditions can bring daily pain, fatigue and disruption that isn't always visible to the people around them.

Many people with these conditions rely on injectable antibody medicines, requiring regular needles, clinic visits or self-injection. This burden can hinder long-term treatment. Delivering these proven medicines without injections could improve access for hundreds of thousands of Australians.

This study is exploring whether delivering two already-approved antibody medicines directly into the colon via a colonoscopy procedure, rather than by injection, allows the body to absorb them more effectively.

As a healthy volunteer, you won't be treating a condition yourself, but you'll be playing an important role in helping researchers understand this new delivery method. 
This study delivers two already-approved antibody medicines directly into the colon via colonoscopy under twilight sedation, no needle required. All participants receive an active treatment; there is no placebo in this study. The procedure is followed by a 48-hour monitored stay at our clinic, with outpatient follow-up visits on Days 4, 5, 6, 7 and 14.
Eligibility

Do you qualify?

Aged 18–45
In good health condition
BMI between 18.0 and 32.0 kg/m², weighing between 50 and 100 kg
Currently pregnant, breastfeeding, or planning to become pregnant
No history of significant liver, kidney, heart, gut, immune, or mental health conditions
No alcohol use over 10 standard drinks per week, or history of substance use in the last 5 years
What's involved

Commitment and procedures

Visit type
day and overnight
total visits
7
duration
3-6 weeks
treatment
Colonic infusion

procedures

Medical history
ECG (electrocardiogram)
Blood sample collection
Urine sample collection
In-clinic bowel preparation 24h + colonoscopy twilight sedation
Screening for hepatitis B and C, HIV, tuberculosis, drugs and alcohol

treatment design

This study involves a single dose of antibody medicines delivered directly into the colon, rather than by injection or tablet, via a colonoscopy procedure performed under twilight sedation. All participants receive an active treatment; there is no placebo group. 

Bowel preparation is completed in-clinic 24 hours before the procedure. Following the colonoscopy, participants remain at our Maroochydore clinic for a 48-hour observation period, with outpatient follow-up visits on Days 4, 5, 6, 7 and 14 to monitor safety and how the treatment is absorbed. All procedures will be explained clearly, and participants can ask questions at any time.
More information

Have questions? We're here to help.

Contact our recruitment team directly, they're happy to answer any questions before you apply for the needle-free medicine study. Please do not send personal medical information by email.
Phone
+07 5409 8640
Hours
Mon–Fri, 8am–5pm
Trial at a glance
Status
enrolling
Phase
phase I
Therapeutic Area
Ages
18-45
Duration
3-6 weeks
Visits
3 nights + follow-ups
Location
Maroochydore clinic
PROTOCOL
SDL-001-101
Reimbursement
Up to $9700

Ready to check your eligibility?

It takes less than 2 minutes to fill healthy volunteer trial form for IBD.
Apply for this trial →
We won't share your details with third parties.
This trial has been reviewed by an independent human research ethics committee.

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