HK inno.N said it completed a phase 1 study of K-Cab (ingredient: tegoprazan), a gastroesophageal reflux disease (GERD) treatment, in the U.S.

In a public disclosure on Thursday, HK inno.N said it finished the phase 1 trial in 30 healthy adults. The study was randomized, double-blind, placebo-controlled, and repeated-administered.

The company administered tegoprazan 25mg, 50mg, and 100mg orally for seven days, respectively, and evaluated the drug’s pharmacokinetic and pharmacodynamic properties and safety.

For each dose cohort, the company enrolled 10 participants (eight receiving tegoprazan, two, placebo) and administered oral tegoprazan or placebo once daily for seven days.

The company collected blood to confirm pharmacokinetics and monitored gastric pH levels to check pharmacodynamics.

The study results showed that the tegoprazan levels in the blood were proportional to the dose. In addition, the levels were similar between day one and day seven after the administration.

In the pharmacodynamics evaluation, tegoprazan demonstrated high acidity compared to placebo for 24 hours on days one and seven. The treatment showed an immediate effect regardless of the dose on day 1.

No death or serious adverse event occurred in all participants who received tegoprazan.

Also, there were no clinically significant abnormalities or changes in clinical laboratory tests, vital signs, and electrocardiograms.

HK inno.N said it would use phase 1 trial results as evidence for a next-stage study in the U.S.

Braintree Laboratories, a U.S. partner for HK inno.N, will conduct the next study.

In December last year, HK inno.N signed a $640 billion licensing deal with Braintree Laboratories, a subsidiary of Sebela Pharmaceuticals which focuses on gastroenterology.

Braintree Laboratories owns the right to develop and commercialize tegoprazan in the U.S. and Canada.

HK inno.N CEO Kwak Dal-won said, with the completion of the U.S. phase 1 study, the company would closely work with the U.S. partner company so that K-Cab, a Korean-made novel drug, could successfully arrive in the U.S. market.

K-Cab is a P-Cab class GERD treatment, authorized as the nation’s 30th novel drug.

The treatment has been licensed to 27 countries, including China and the U.S.

In China, Shandong Luoxin Pharmaceutical Group seeks to win approval for K-Cab and release the drug in the first half of 2022.